- Female subjects who are sexually active and of childbearing potential, i.e. not surgically sterile (tubal ligation, bilateral oopherectomy, or hysterectomy) or at least 2 years naturally postmenopausal must agree to use an acceptable form of contraception from Screening through completion of the study. Acceptable forms of contraception for this study include hormonal contraceptives (oral, implant, transdermal patch, or injection) at a stable dose for at least 3 months prior to Screening, barrier (spermicidal condom or diaphragm with spermicide), IUD, or a partner who has been vasectomized for at least 6 months. [NB: Childbearing potential is defined as a female who has reached menarche.]